Category: Part 11

26 Oct 2017

eSOURCE…We changed the game, AGAIN!

The clinical research industry has inevitably been slow to adopt technological advances primarily due to regulatory constraints and a fear of change that could disrupt current processes.  While the regulatory guidance has been issued by the FDA, development of solutions that can conform to the guidance AND improve efficiency is challenging.

In the recent years, there has been a shift in favor of technology because software companies like RealTime have found a way to develop solutions that improve efficiency in a user-friendly environment and meet all the regulations needed to be used in the clinical research industry.

As a result of these advancements, RealTime has turned into a key player and trendsetter in the CTMS world.  During the 2017 Global Site Solutions Summit in Boca Raton, FL, RealTime showcased its newest solution, eSOURCE, which will revolutionize how sites collect study data and how sponsors and CROs review and transfer that data into EDC systems.  Further, RealTime is the only CTMS company that can integrate CTMS, eSOURCE, eDOCS, PAY and TEXT all into a single platform.  Sites that embrace these integrated solutions will experience unparalleled efficiencies.

eSOURCE like all the other RealTime solutions is capable of being used as a stand-alone system or can be fully integrated into other systems. Its comprehensive set of features give sites more features, greater scalability, and better support, all at an affordable price. RealTime-eSOURCE is also a fully-validated, Part-11 complaint system, so sites and sponsors can feel confident that it meets FDA regulations for electronic source data collection.

RealTime is committed to bringing new and innovative solutions to the clinical research industry that will enhance efficiencies, saving time and money and ultimately speeding up the process of delivering new medical therapies to the world.

Contact RealTime today if you would like to learn more about our solutions and/or set up a personalized demonstration of our systems.




14 Aug 2017

RealTime is Changing the CTMS Industry with First-of-its-Kind New App

Research sites can now access popular eDOCS solution on mobile device with new app

SAN ANTONIO—Want to access site eRegulatory files, sign documents with your thumb print, refer a patient to a study or look up site and sponsor contacts all on your mobile device? There’s an app for that!

RealTime-CTMS launched the first-of-its-kind new app this week that allows site staff to use its popular eDOCS solution from an iOS or Android device.

“No other CTMS or eRegulatory system has mobile capabilities like we do,” says RealTime-CTMS CEO, Rick Greenfield. “The ease at which sites can access pertinent information including inclusion and exclusion information, sign documents using finger print technology and even refer patients directly into the CTMS system can’t be matched.”

eDOCS is a cutting-edge system that can be fully integrated with RealTime-CTMS or used as a stand-alone system. The solution enables sites to go fully digital, eliminating messy regulatory binders and paper work. eDOCS has already made a splash in the clinical research world and with the release of the app, industry leaders are expecting the solution to continue to grow in popularity.

“Everything is going mobile, even the clinical trial industry,” says Greenfield. “With the tap of a button on your mobile device, sites now have instant access to information that would otherwise have to be found in bulky binders and loads of paperwork.”

Some features of the new app include the ability for investigators to sign documents using iOS and Android finger print technologies, easy access to site and sponsor contacts on the go and push notifications that alert investigative staff that requests for signatures are pending. The app also allows site staff to refer a patient into a study and instantly access protocol and study information.

“We are very excited about the launch of our app and believe it will greatly increase efficiency and success across our sites,” says Greenfield.

For more information on eDOCS mobile, download the app at the App Store or on Google Play.

About RealTime-CTMS

RealTime Software Solutions, LLC is located in San Antonio, TX and is a leader in database-driven, cloud-based clinical research software solutions. Our focus is on research sites and our goal is to solve problems and provide systems that make the sites more efficient and more profitable. We are constantly listening to our customers to provide new innovations that improve performance and help sites achieve their goals.

09 May 2016
FDA Part 11 Compliance Compliant

What is 21 CFR Part 11?

fda (3)With Part 11 compliant systems now available for investigator sites to streamline processes, some of us are wondering what exactly is 21 CFR Part 11 and why is it important?  Essentially, 21 CFR Part 11 regulations define the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records. Basically, Part 11 allows companies to replace any paper record or hand written signature with an electronic record/signature.

For years now, computers have made individuals more productive while eliminating costs associated with paper-based systems. It’s natural that investigator sites are now wanting to replace paper with electronic records to boost efficiency.  The truth is, every investigator site already has electronic records but most companies are so unsure of Part 11 compliance that they resort to printing paper in fear of being non-compliant with regulations.  Instead of fearing Part 11, it’s much more beneficial to embrace these regulations and realize that Part 11 compliance is not complicated.  Can you imagine a research site with a lot less paper?  Not only does Part 11 make this possible, many research sites are already leading the way to an electronic future by adopting systems that manage their regulatory documentation electronically.

While Part 11 regulations are essential and helpful, many would argue that the actual document lacks detail on implementation.  With the lack of detail, the FDA has since provided guidance documents to assist in implementation and the industry has adopted standards to ensure compliance.

There are three primary areas of 21 CFR Part 11 compliance:

1) Standard Operating Procedures – The software vendor will have about 10 or more SOPs to address their IT infrastructure. These SOPs include, but are not limited to, Data Backup, Data Security, Computer System Validation, and other aspects of computer systems that support electronic records and signatures. It’s important for research sites to explore their own IT infrastructure to ensure SOPs that maintain compliance at the site level.

2) Computer system features – There are numerous standard product features that are implemented to ensure computer system security and data integrity. These features include complete audit trails, access controls, record retention and electronic signatures.

3) Computer System Validation – Part 11 compliant systems must have documented evidence that the system does what is intended. Furthermore, users should be trained to detect when the system is not working as intended.

Through Part 11 regulations, the FDA has paved the way to an electronic future for research sites.  Adopting a Part 11 system doesn’t take an act of faith but it does require a systematic approach to compliance.  If you want to see how other sites are ditching the paper regulatory binders and moving towards electronic freedom, visit our website to learn more about RealTime-eDOCS.  Better yet, contact us for an online demo to see the system in action!


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